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Medical Device Software Testing Jobs in Merrimack, NH

Danaher

Software Engineer Internships

Concord, NH · On-site

Participating on an Agile Scrum team, collaborating across design, development, and testing ... Producing documentation to support medical device regulatory processes Who This Is For * Students ...

Danaher

Software Engineer Internships

Manchester, NH · On-site

Participating on an Agile Scrum team, collaborating across design, development, and testing ... Producing documentation to support medical device regulatory processes Who This Is For * Students ...

Danaher

Software Engineer Internships

Nashua, NH · On-site

Participating on an Agile Scrum team, collaborating across design, development, and testing ... Producing documentation to support medical device regulatory processes Who This Is For * Students ...

Danaher

Software Engineer Internships

Lowell, MA · On-site

Participating on an Agile Scrum team, collaborating across design, development, and testing ... Producing documentation to support medical device regulatory processes Who This Is For * Students ...

Danaher

Software Engineer Internships

Derry, NH · On-site

Participating on an Agile Scrum team, collaborating across design, development, and testing ... Producing documentation to support medical device regulatory processes Who This Is For * Students ...

Globus Medical

Software Engineer

Methuen, MA · On-site

Contributes to design, testing and documentation. * Supports the development of manufacturing test ... Experience in Medical Device field a plus * Ability to work independently and as a key contributor ...

Globus Medical

Software Engineer

Methuen, MA · On-site

Contributes to design, testing and documentation. * Supports the development of manufacturing test ... Experience in Medical Device field a plus * Ability to work independently and as a key contributor ...

Connexion Systems & Engineering, Inc.

Be Seen First

Manufacturing Technician

Manchester, NH · On-site

$20 - $23/hr

Kitting assemblies using a parts list, scanner and inventory software as required. * Participates ... assembly, testing and the documentation of mechanical and electrical devices * Medical device ...

Access Vascular

Sr. Systems Engineer

Billerica, MA · On-site

$120K - $155K/yr

Lead the design and development of a medical device with electrical, software, and mechanical ... Standards Compliance & Regulatory Testing: Plan and manage testing to applicable standards ...

Access Vascular

Sr. Systems Engineer

Billerica, MA · On-site

$111K - $151K/yr

Lead the design and development of a medical device with electrical, software, and mechanical ... Standards Compliance & Regulatory Testing: Plan and manage testing to applicable standards ...

Access Vascular

Sr. Systems Engineer

Billerica, MA · On-site

$120K - $155K/yr

Lead the design and development of a medical device with electrical, software, and mechanical ... Standards Compliance & Regulatory Testing: Plan and manage testing to applicable standards ...

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Showing results 41-60

All JobsMedical Device Software Testing JobsMedical Device Software Testing Jobs in Merrimack, NH

Medical Device Software Testing information

See Merrimack, NH salary details

$19

$44

$71

How much do medical device software testing jobs pay per hour?

As of Aug 17, 2026, the average hourly pay for medical device software testing in Merrimack, NH is $44.54, according to ZipRecruiter salary data. Most workers in this role earn between $34.23 and $53.65 per hour, depending on experience, location, and employer.

What is medical device software testing?

Medical device software testing is the process of verifying and validating the software used in medical devices to ensure it is safe, reliable, and compliant with regulatory standards. This involves various testing methods, such as functional, performance, and usability testing, to identify and fix potential issues before the device is released to the market. Proper software testing helps prevent device failures that could harm patients and ensures that the device operates as intended under all expected conditions.

What are the key skills and qualifications needed to thrive as a medical device software tester?

To excel as a Medical Device Software Tester, you need a strong background in software testing methodologies, knowledge of regulatory standards like IEC 62304, and a degree in computer science or engineering. Familiarity with testing tools such as Selenium, Jira, and automated test frameworks, as well as experience with validation and verification documentation, is typically required. Attention to detail, analytical thinking, and effective communication are crucial soft skills that help testers identify issues and collaborate with cross-functional teams. These skills and qualifications are vital to ensure the safety, reliability, and compliance of medical device software in a highly regulated industry.

What are some common challenges faced by professionals in medical device software testing, and how can they be addressed?

Professionals in medical device software testing often encounter challenges such as ensuring compliance with strict regulatory standards (like FDA or ISO 13485), managing complex documentation requirements, and keeping up with frequent software updates. Addressing these challenges requires a strong focus on detail, thorough understanding of relevant regulations, and effective communication with development and quality assurance teams. Collaborating closely with cross-functional teams and maintaining up-to-date knowledge of regulatory changes are key to successfully navigating these demands.

What is the difference between Medical Device Software Testing vs Medical Device Quality Assurance?

AspectMedical Device Software TestingMedical Device Quality Assurance
CertificationsISTQB, CSTE, or similar testing certificationsISO 13485, CAPA, or quality management certifications
Work EnvironmentTesting labs, development teams, regulated environmentsQuality management systems, compliance departments
Employer & Industry UsageMedical device companies, software developersManufacturers, regulatory agencies, compliance firms
Search & Comparison IntentUnderstanding testing roles, skills, and responsibilitiesUnderstanding quality assurance processes, compliance standards

Medical Device Software Testing focuses on verifying and validating software functionalities to ensure safety and compliance. Medical Device Quality Assurance encompasses broader quality management practices, including process audits and compliance to standards. Both roles are essential in the medical device industry but serve different purposes in ensuring product safety and regulatory adherence.

Medical Device Software Testing jobs near you
Infographic showing various Medical Device Software Testing job openings in Merrimack, NH as of August 2026, with employment types broken down into 1% As Needed, 75% Full Time, 18% Part Time, and 6% Contract. Highlights an 89% Physical, 1% Hybrid, and 10% Remote job distribution, with an average salary of $92,649 per year, or $44.5 per hour.

Senior Software Quality Assurance Engineer

Katalyst Healthcares and Lifesciences

Andover, MA • On-site

Other

Posted 3 days ago

New

Job description

  • As a Senior Design Quality Engineer (DQE) for our medical device manufacturer client in the Greater Boston region, you will be responsible for ensuring end-to-end design quality and compliance across the product development lifecycle for Class II/III medical devices, including software-driven and active implantable products.
  • Working directly with cross-functional teams, you will drive adherence to design controls, risk management, and SDLC best practices from concept through commercialization and post-market activities.
Key Responsibilities
In this role you will play a key role in:
  • Serving as the quality lead on product development teams, ensuring compliance with design controls across all lifecycle phases (planning, inputs/outputs, verification, validation, transfer, and change management)
  • Establishing and maintaining DHF, DMR, and DHR, ensuring complete traceability from user needs through verification and validation evidence
  • Leading and maintaining risk management activities (hazard analysis, FMEA, risk files) and ensuring integration of risk controls into design and validation activities
  • Providing quality oversight of software SDLC activities, ensuring compliance with applicable standards (e.g., IEC 62304) and integration with system-level risk management
  • Reviewing and approving design, software, and validation deliverables to ensure completeness, consistency, and audit readiness
  • Supporting verification, validation, and design transfer activities, ensuring alignment between design outputs and production processes
  • Leading or supporting CAPA, nonconformance investigations, and root cause analysis to drive continuous improvement
  • Supporting internal and external audits (FDA, Notified Body, ISO), and contributing to regulatory submissions (e.g., IDE, PMA, EU MDR)
Required Skills
  • 10+ years of experience in Quality Engineering supporting regulated medical device development (Class II/III preferred)
  • Strong hands-on experience with design controls, DHF management, and traceability in regulated environments
  • Working knowledge of applicable standards and regulations (e.g., 21 CFR 820, ISO 13485, ISO 14971, IEC 62304)
  • Experience supporting software quality within the SDLC and understanding of software risk management principles
  • Proven experience with risk management tools (e.g., FMEA, hazard analysis) and integration into product development
  • Experience supporting audits and regulatory submissions, with the ability to defend design and quality documentation
  • Strong analytical, documentation, and communication skills with ability to work effectively across cross-functional teams
  • Experience with quality systems, eQMS/PLM tools, and defect/CAPA management processes

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